Identity
- Trade Name
- Map-iT FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
- Device Name
- Steerable Decapolar PV Catheter, Pulmonary Vein 15 FDA UDI
- Model / Reference
- 901642 FDA UDI
- Description
- Steerable Decapolar PV Catheter, Pulmonary Vein 15 FDA UDI
Identifiers
- Catalog Number
- 901642 FDA UDI
- Primary DI / UDI-DI
- 00818087020039 FDA UDI
- 510(k) Number
- K160390 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDILength — 110 Centimeter FDA UDI
Category: Cardiac mapping catheter, percutaneous, single-use
Map-iT by Access Point Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping catheter, percutaneous, single-use.
- Viking™ — Boston Scientific · Class II
- Inquiry™ AFocus II™ — IRVINE BIOMEDICAL, INC. · Class II
- Woven — Boston Scientific · Class II
- Woven — Boston Scientific · Class II
- AcQRate Dx Steerable Catheter — VascoMed GmbH · Class II
- Inquiry™ — IRVINE BIOMEDICAL, INC. · Class II
- Woven — Boston Scientific · Class II
- Inquiry™ — IRVINE BIOMEDICAL, INC. · Class II
Cleared under the same submission
K160390 also covers:
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Access Point Technologies, Inc.
Sources (1)
- FDA UDI a1b7c254-d718-4e9e-847b-9de8056f7fa8 37 fields · synced Jun 8, 2026